food safety modernization act (fsma) & imports of food ......preventive controls for human food...

Food Safety Modernization Act (FSMA) &

Imports of Food Products

August 9th, 2016

Russell Statman, Registrar Corp

Background

TIMELINE OF U.S. FOOD REGULATION

Until 1906

“The Jungle”

Background

TIMELINE OF U.S. FOOD REGULATION

1906 Meatpacking Scandal

The Food and Drug Act

FDA FOOD SAFETY MODERNIZATION

ACT (“FSMA”)

1938

The Food, Drug and Cosmetic Act

Statutory Mandate to FDA Concerning Food:

Respond to Food Safety Violations

FDA Food Safety Modernization Act

(FSMA)

“HACCP”: Hazard Analysis and Critical

Control Points

Background

FDA FOOD SAFETY MODERNIZATION ACT

(“FSMA”)

Enacted by Congress and signed into law on

January 4, 2011

New Mandate: Prevent Foodborne Illness


(FSMA)


(FSMA)

THE LAW REQUIRED FDA TO ISSUE

SEVEN MAJOR SETS OF RULES: Preventive Controls for Human Food

Preventive Controls for Animal Food

Produce Safety

Foreign Supplier Verification Program

Third Party Auditor

Sanitary Transportation

Intentional Adulteration

Also: Voluntary Qualified Importer Program

Preventive Controls for Human Food

Final rule was published September 17, 2015

Effective dates:

September 17, 2016: Companies > 500 employees

September 17, 2017: Companies < 500 employees

but > $1M in global sales or inventory

September 17, 2018: Companies < $1M in global

sales or inventory

Compliance Dates

Supply-Chain Program

• Separate compliance dates have been established for

the supply-chain program provisions to accommodate

compliance dates for suppliers of different sizes and

subject to different rules

(e.g., Produce Safety Standards, Foreign Supplier

Verification Program)

FSVP: When Must I Comply?

Compliance is the latest of:

May 27th, 2017 (18 months after publication of final rule)

Or

If supplier is subject to the preventive controls or produce

safety regulations, 6 months after the foreign supplier of

the food is required to comply with the relevant regulations

Preventive Controls for

Human Food

Establishes a new 21 CFR Part 117 to replace 21

CFR Part 110

(current Good Manufacturing Practices)

Preventive Controls for

Human Food

Who is Covered?

Most food facilities that are required to register with FDA

(Facilities that manufacture, process, pack or hold food)

Some exemptions and modified requirements may apply (seafood,

juices, alcoholic beverages, low acid and acidified foods, storage

facilities, companies with annual sales or inventory < $1M)

•

Farms May Be Subject to the FSMA Produce Safety Final Rule!

Retail Establishments May be Subject to FSVP Rule!

Companies with < $1M Have New Attestation Requirements!

Food Safety Plan

Must be written by one or more “preventive controls

qualified individuals” and signed by owner, operator or

agent in charge

Must include:

-Hazard analysis

-Preventive controls

-Supply-chain program

-Recall plan

-Procedures for monitoring

-Corrective action procedures

-Verification procedures

“Preventive Controls

Qualified Individual”

• A “preventive controls qualified individual is a “qualified

individual” who has successfully completed training in the

development and application of risk-based preventive controls at

least equivalent to that received under a standardized curriculum

recognized as adequate by FDA or is otherwise qualified through

job experience to develop and apply a food safety system.

• “Qualified individual” means a person who has the education,

training, or experience (or a combination thereof) necessary to

manufacture, process, pack, or hold clean and safe food as

appropriate to the individual’s assigned duties. A qualified individual

may be, but is not required to be, an employee of the establishment.

Reanalysis of

Food Safety Plan

-At least every three years

-Whenever there is a significant change that creates the potential for a

new hazard or a significant increase in one previously identified

-When there is new information about potential hazards associated

with a food

-When a preventive control is ineffective

Food Safety Plan

- Hazard Analysis

Hazard identification must consider known or reasonably

foreseeable biological, chemical and physical hazards:

-Naturally occurring

-Produced unintentionally

-Introduced intentionally for economic gain

Food Safety Plan – Preventive

Controls

Measures required to control hazards:

Process controls

Food allergen controls

Sanitation controls

Supply-chain controls

Recall plan

Food Safety Plan – Monitoring

The facility must have written procedures for monitoring

the preventive controls Including:

-The frequency

they are to be performed

-Appropriate to the nature

of the preventive control

Monitoring must be documented in records and are subject

to verification

Food Safety Plan -

Verification

Includes (as appropriate):

-Validation of preventive controls

-Verification of monitoring and corrective actions

-Calibration of instruments

-Product testing

-Environmental monitoring

-Records review

Supply Chain Program

Manufacturing/processing facilities must have a risk-based

supply-chain program to ensure control of hazards in raw

materials and other ingredients when the control is applied

before receipt (“supply-chain applied control”).

Supply Chain Program

• Use of approved suppliers

• Determine appropriate supplier verification activities

• Conduct and document supplier verification activities,

including FDA compliance history

• When applicable, verify a supply-chain-applied control

applied by an entity other than the facility’s supplier or

obtain documentation of verification by another entity

FDA Compliance Monitor

Supplier Verification Activities

• Onsite audits (annually as default for serious

hazards)

• Sampling and testing

• Review of relevant food safety records

• Other as appropriate

Circumstances Where Preventive Controls Are

Not Required By Processors

1. The processor determines and documents that the type

of food could not be consumed without application of an

appropriate control (e.g., cocoa beans)

Circumstances Where Preventive

Controls Are Not Required By

Processors

2. The hazard is controlled downstream and the manufacturer obtains annual

written assurances or establishes its own downstream controls

a) Documents accompanying the food must disclose: “not processed

to control [identified hazard].”

b) Annual written assurances from customer or customer's customer

that hazard is being controlled downstream and customer promises

not to sell to entity that does not assure in writing.

Foreign Supplier Verification Program (FSVP)

Importers must provide adequate assurances that:

Foreign suppliers produce food using processes

and procedures providing same level of public health

protection as FSMA preventive controls or produce safety

provisions

-and-

Food is not adulterated or misbranded (as to

allergen labeling)


(FSVP)

Who must Comply?

“Importer” defined as owner or consignee of food.

*If there is no US owner or consignee, the “Importer” is the

U.S. agent or representative of the foreign owner or

consignee, as confirmed in signed statement of consent.

Foreign Supplier Verification

Program (FSVP)

Importer identification at entry

FOOD SAFETY MODERNIZATION ACT

FOREIGN SUPPLIER VERIFICATION PROGRAM

General Requirements of the FSVP

A “Qualified Person” Must Perform the Following:

*Hazard Analysis

*Supplier Verification Activities

(including compliance status review of suppliers)

*Corrective Actions

*Periodic Reassessment of FSVP

*Importer Identification at Entry

*Record-keeping


(FSVP)

To approve suppliers, Importers must consider:

-Risk posed by the food (hazard analysis)

-Entities controlling hazards or verifying control

-Supplier characteristics (procedures and practices; FDA

compliance history, Warning Letters, Import Alerts)


Program (FSVP)


- Procedures to ensure food is obtained from approved suppliers

- Written procedures for verification activities

- Determine appropriate verification activities (and frequency) based on

food and supplier evaluation

-Activities may include: onsite auditing; sampling and testing; review of

supplier records; other appropriate measures

**Annual onsite auditing is default approach when a food has a

SAHCODHA hazard (Serious Adverse Health Consequences or Death

to Humans or Animals).


Program (FSVP)


May rely on another entity’s determination or performance of

appropriate verification activities (e.g., farm audits by produce

distributor, BRC, inspection by FDA)

Must review and assess results of verification activities (importer’s own

or others on which it relies)


Program (FSVP)

Countries With Equivalent Food Safety Systems

Importer must document that:

Foreign supplier is under oversight of comparable

or equivalent food safety system.

Food is within scope of official recognition or

determination.

Supplier is in good compliance standing with

comparable or equivalent food safety authority.


Program (FSVP)

FSVP EXEMPTIONS

Firms subject to juice or seafood HACCP regulations

Food for research or evaluation

Food for personal consumption

Alcoholic beverages and ingredients (when importer uses them to

make an alcoholic beverage)

Food transshipped through U.S.

Food imported for processing and export

“U.S. food returned”

Meat, poultry, and egg products subject to USDA regulation at time of

importation


Program (FSVP)

Special Circumstances

The food cannot be consumed without application of control (e.g.,

coffee beans)

Hazard controlled by importer’s customer or subsequent entity in US

distribution.

Disclosure statement

Written assurance

Other system to ensure control of hazard at subsequent distribution

step


Program (FSVP)

Small Businesses

Very small importer (VSI)

Less than $1 million/yr. in human food sales

Less than $2.5 million/yr. in animal food sales

Food from certain small suppliers

Qualified facility (same $ as VSI)

Produce from certain small suppliers that are not covered farms

Shell egg producers with < 3,000 laying hens

•


Program (FSVP)

Small Businesses

Annually document eligibility

Verification: Written assurances from suppliers

Additional requirements for food from small suppliers:

Evaluate supplier compliance history

Approve suppliers

Ensure food is from approved suppliers

Attestation

FSMA Compliance Wizard

Final Advice

Questions?

• Registrar Corp Headquarters

• 144 Research Drive

• Hampton, Virginia

• USA 23666

• P: +1-757-224-0177

• F: +1-757-224-0179

• E: [email protected]

•